Research

Oxymorphone HCL for Postoperative Pain Management – Phase III

Evaluation of the Effectiveness, Safety, and Tolerability of Oral Liquid Oxymorphone HCl Immediate-Release Oral Liquid for Acute Postoperative Pain in Pediatric Subjects

Protocol Description

The purpose of this study is to evaluate the effectiveness, tolerability and safety of oxymorphone HCL immediate-release (IR) oral liquid when used to relieve acute postoperative pain in pediatric patients. Although approved by the U.S. Food and Drug Administration for treating moderate to severe pain in adults, it has not yet been approved for use in children.

Study Level: Phase III

Eligibility Criteria

Subject to certain exclusions, this study is open to patients of both genders, from infants through age 12, who are scheduled for a surgical procedure.
Males: Infant to 12 years
Females: Infant to 12 years

Requirements
Participants will be randomly assigned to Part 1 or Part 2 of the study. Participants in the first group will receive a single dose of the study drug following surgery. Those in the second group will receive multiple doses – 1 following surgery and 1 dose every 4 to 6 hours for up to 48 hours. During the postoperative period, researchers will follow-up with participants at specified intervals to assess their level of pain management and other vital functions.
Visits: Requires hospitalization for surgery
Duration: 24 hours for participants in Part 1, and 48 hours for Part 2

Status: Enrolls only pediatric patients for whom surgery is planned

Source(s) of Support
Endo Pharmaceuticals Inc.

Additional Information
Study Description at National Institutes of Health

Primary Investigator(s)

Mihaela Visoiu, MD

Contact Information

For information, please contact:
Denise McCarthy RN, CRC
412-692-5585

Last Update
July 21, 2011
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Last Update
July 21, 2011
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